| CTRI Number |
CTRI/2019/10/021577 [Registered on: 09/10/2019] Trial Registered Prospectively |
| Last Modified On: |
08/10/2019 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
|
Public Title of Study
|
Comparison of various Pediatric Early Warning Scores as a Predictor of Clinical deterioration and Mortality in Malnourished Children |
|
Scientific Title of Study
|
Comparison of Pediatric Early Warning Scores in Malnourished Children in Emergency A prospective observational study |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Varuna Sugha |
| Designation |
Junior Resident |
| Affiliation |
PGIMER |
| Address |
Department of Pediatrics
Advanced Pediatrics Centre
PGIMER
Chandigarh
CHANDIGARH
160012
India |
| Phone |
9816154282 |
| Fax |
|
| Email |
vsugha@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Arun Bansal |
| Designation |
Professor |
| Affiliation |
PGIMER |
| Address |
Department of Pediatrics
Advanced Pediatrics Centre
PGIMER
Chandigarh
CHANDIGARH
160012
India |
| Phone |
9815455002 |
| Fax |
|
| Email |
drarunbansal@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Varuna Sugha |
| Designation |
Junior Resident |
| Affiliation |
PGIMER |
| Address |
Department of Pediatrics
Advanced Pediatrics Centre
PGIMER
Chandigarh
CHANDIGARH
160012
India |
| Phone |
9816154282 |
| Fax |
|
| Email |
vsugha@gmail.com |
|
|
Source of Monetary or Material Support
|
| Post Graduate Institute od Medical Institution and Research
Chandigarh |
|
|
Primary Sponsor
|
| Name |
PGIMER |
| Address |
Advanced Pediatrics Centre
PGIMER
Chandigarh |
| Type of Sponsor |
Research institution and hospital |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Arun Bansal |
PGIMER |
Department of Critical Care
Advanced pediatrics centre
PGIMER
chandigarh
Chandigarh
CHANDIGARH |
9815455002
drarunbansal@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| PGIMER ethics committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
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Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: O||Medical and Surgical, |
|
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Intervention / Comparator Agent
|
|
|
Inclusion Criteria
|
| Age From |
1.00 Month(s) |
| Age To |
12.00 Year(s) |
| Gender |
Both |
| Details |
All malnourished children presenting to emergency room of APC PGIMER
Age > 1 month to <12 years |
|
| ExclusionCriteria |
| Details |
Malnourished children brought to ER in cardiopulmonary arrest or died within one hour of presenting. |
|
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Method of Generating Random Sequence
|
|
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Method of Concealment
|
|
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Blinding/Masking
|
|
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Primary Outcome
|
| Outcome |
TimePoints |
| To evaluate different padiatric early warning scores in malnourished patients in predicting mortality and clinical deterioration |
,6 hours, 12 hours, 18 hours, 24 hours, 32 hours, 40 hours, 48 hours or till mortality or clinical deterioration occurs(within 48 hours) |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To compare different PEWS in different age groups as an indicator to predict mortality and clinical deterioration. |
,6 hours, 12 hours, 18 hours, 24 hours, 32 hours, 40 hours, 48 hours or till mortality or clinical deterioration occurs(within 48 hours) |
|
|
Target Sample Size
|
Total Sample Size="500"
Sample Size from India="500"
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
15/10/2019 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="1"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
Nil |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
The study will be conducted at Emergency Room, Dept. of Pediatrics, Advanced Pediatric Centre, Postgraduate Institute of Medical Education and Research, Chandigarh.Sample Size: All malnourished patients presenting to Advanced Paediatric Centre Emergency Room Inclusion Criteria: All malnourished children presenting to emergency room of PGIMER; Age > 1 month to <12 years Exclusion criteria: Malnourished children brought to ER in cardiopulmonary arrest or died within one hour of presenting.
Children admitted in ER, meeting the malnutrition criteria will be selected by a using a Case Screening Performa on day 1 of their admission . Enrolment will be done only after obtaining written informed consent Pews Scores to be tested: 1. Brighton PEWS (Monaghan) 2. Bedside PEWS(Parshuram et al) 3. Cardiff and Vale PEWS(Edwards et al) 4. C CHEWS PEWS(McLellan et al) 5. Birmingham and Toronto PEWS(Duncan et al) Data collection: Various clinical parameters will be assessed as per the different paediatric early warning scores at different intervals from admission to outcome .. Time point of data collection: At admission followed by 6 hourly intervals for 24 hours and 8 hourly thereafter i.e. admission ,6 hours, 12 hours, 18 hours, 24 hours, 32 hours, 40 hours, 48 hours or till mortality or clinical deterioration (defined as need for intubation, shift to picu, need for inotropes or cardiopulmonary arrest)occurs(within 48 hours). PEWS Documentation: Clinical parameters are documented by residents posted in the emergency room in monitoring charts used in APC, PGIMER. The PEWS score will be calculated and documented based on these records Numeric score will be calculated for the different scoring systems. A PEW score will be calculated for each interval during the defined 48 hour period. The validity and comparison of the PEWS will be expressed by the areas under the receiver operating characteristic (ROC) curves, sensitivity and specificity ,positive likelihood ratios and negative likelihood ratios . ROC analysis will be performed to study the ability of various scores to predict clinical deterioration. The area under curve (AUC) will be used as a measure of overall performance of ROC curve , in this case, the ability of each score to predict clinical deterioration or mortality of the malnourished child |